search
Back to results

The Effect of Fasudil on Vascular Function in Humans

Primary Purpose

Atherosclerosis, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fasudil
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Coronary artery disease Hyperlipidemia -OR- Healthy adults Exclusion Criteria: Unstable angina, myocardial infarction or revascularization within 3 months Symptomatic heart failure Creatinine > 3.0 mg/dl Liver enzymes > 3X upper limit of normal Chronic hypoxia Significant anemia Chronic inflammatory disease Pregnancy Willing to withdraw statins for duration of study

Sites / Locations

  • Brigham and Women's Hospital

Outcomes

Primary Outcome Measures

Vascular reactivity

Secondary Outcome Measures

Rho kinase expression
Rho kinase activity
eNOS expression
eNOS activity
inflammatory markers

Full Information

First Posted
July 12, 2005
Last Updated
September 26, 2008
Sponsor
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00120718
Brief Title
The Effect of Fasudil on Vascular Function in Humans
Official Title
The Effect of Fasudil on Vascular Function in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fasudil
Primary Outcome Measure Information:
Title
Vascular reactivity
Secondary Outcome Measure Information:
Title
Rho kinase expression
Title
Rho kinase activity
Title
eNOS expression
Title
eNOS activity
Title
inflammatory markers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Coronary artery disease Hyperlipidemia -OR- Healthy adults Exclusion Criteria: Unstable angina, myocardial infarction or revascularization within 3 months Symptomatic heart failure Creatinine > 3.0 mg/dl Liver enzymes > 3X upper limit of normal Chronic hypoxia Significant anemia Chronic inflammatory disease Pregnancy Willing to withdraw statins for duration of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Creager, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Fasudil on Vascular Function in Humans

We'll reach out to this number within 24 hrs